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Effect of Fish Oil on Hyperlipidemia and Toxicities in Children and Young Adults With Acute Lymphoblastic Leukemia

NCT ID: NCT04209244

Last Updated: 2019-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-16

Study Completion Date

2029-12-31

Brief Summary

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Acute lymphoblastic leukemia (ALL) is the most common malignant disease among children. Treatment results have improved over time due to intensive risk-adapted therapy and the 5-year survival rate is now above 90%. However, the burden of therapy has increased proportionally. Many children develop serious acute and chronic side effects, which impact on the patients expected lifespan and impair their quality of life as a result of therapy. Treatment with PEG-asparaginase and dexamethasone increases the levels of triglycerides and total cholesterol. Consequently, the incidence of hyperlipidemia is high during initial ALL therapy. Studies have suggested that hyperlipidemia is a risk factor for development of osteonecrosis, thrombosis and possibly acute pancreatitis.

Long-chained marine omega-3 fatty acids, found in fish oil, decrease levels of triglycerides and total cholesterol in hyperlipidemic patients. Due to the high survival rate, it is of great interest to develop methods to reduce treatment related toxicities.

The investigators hypothesise that daily intake of fish oil will prevent development of hyperlipidemia during ALL treatment phases with dexamethasone and PEG-asparaginase compared to placebo and that fish oil intake may reduce the incidence of severe adverse events related to ALL treatment.

Detailed Description

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Conditions

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Leukemia, Acute Lymphoblastic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fish oil

Eskimo-3 Pure Fish Oil, 10 ml per day (2.6 g EPA+DHA)

Group Type EXPERIMENTAL

Eskimo-3 Pure Fish Oil

Intervention Type DIETARY_SUPPLEMENT

Dosage: 10 ml/day (2.6 g EPA+DHA)

Placebo

Rapeseed Oil, 10 ml per day

Group Type PLACEBO_COMPARATOR

Rapeseed Oil

Intervention Type DIETARY_SUPPLEMENT

Dosage: 10 ml/day (0 g EPA+DHA)

Interventions

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Eskimo-3 Pure Fish Oil

Dosage: 10 ml/day (2.6 g EPA+DHA)

Intervention Type DIETARY_SUPPLEMENT

Rapeseed Oil

Dosage: 10 ml/day (0 g EPA+DHA)

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Fish Oil Placebo

Eligibility Criteria

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Inclusion Criteria

* Children (1-17.9 years) and young adults (18-45 years) diagnosed with ALL, stratified to very-low risk (VRL), intermediate risk low (IR-low) and intermediate risk high (IR-high) in the ALLTogether protocol.

Exclusion Criteria

* Patients diagnosed with ALL, stratified to high risk (HR) after induction treatment or stem cell transplantation in the ALLTogether protocol
Minimum Eligible Age

1 Year

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Child Cancer Foundation

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Renate Dagsdottir Laumann

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Leth Frandsen

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Locations

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Aalborg University Hospital

Aalborg, , Denmark

Site Status NOT_YET_RECRUITING

Aarhus University Hospital

Aarhus, , Denmark

Site Status NOT_YET_RECRUITING

Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Odense University Hospital

Odense, , Denmark

Site Status NOT_YET_RECRUITING

Countries

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Denmark

Central Contacts

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Renate Dagsdottir Laumann, MSc

Role: CONTACT

Phone: +4560163957

Email: [email protected]

Facility Contacts

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Steen Rosthøj, MD

Role: primary

Birgitte Klug Albertsen, MD

Role: primary

Renate Dagsdottir Laumann, MSc

Role: primary

Peder Skov Wehner, MD

Role: primary

Other Identifiers

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H-19054660

Identifier Type: -

Identifier Source: org_study_id